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FDA 510(k)

SignaSure Dual Mobility System

K-Number: K220495 · 2023-01-13

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2023-01-13
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SignaSure Dual Mobility System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2023-01-13 under approval number K220495. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SignaSure Dual Mobility System?

SignaSure Dual Mobility System is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K220495.

When was SignaSure Dual Mobility System approved by the FDA?

SignaSure Dual Mobility System received FDA 510(k) clearance on 2023-01-13, under approval number K220495.

What company makes SignaSure Dual Mobility System?

SignaSure Dual Mobility System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for SignaSure Dual Mobility System?

The FDA product code for SignaSure Dual Mobility System is MEH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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